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FDA Warning Letter Explorer
FDA warning letter · Drugs

DuPont Nutrition USA Inc.

Issued · Posted by FDA

FDA published a close-out letter on Jul 30, 2026. The passages below are from the original warning letter.

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Your firm failed to perform adequate investigation of complaints.

Passage 2

You failed to thoroughly investigate OOS results in a timely manner, appropriately identify root causes, expand investigations to all potentially affected lots, and implement adequate CAPA.

Passage 3

Your firm failed to ensure the test methods used are suitable for their intended use.

Passage 4

Your firm failed to have an adequate change management program to evaluate and approve changes that may impact the quality of the excipient.

Passage 5

Your firm failed to have adequate laboratory control records that include complete and accurate data from tests performed to ensure conformance with specifications and standards, nor did you record activities at the time of performance.